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| Model Number N/A |
| Device Problem
Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was reported that over-insertion of the cook airway exchange catheter resulted in a right side tension pneumothorax in an elderly patient.A (b)(6) year-old man with severe multi-vessel coronary artery disease and worsening anginal symptoms presented for elective coronary artery bypass graft surgery (cabg).Physical examination was remarkable for decreased breath sounds in the bilateral lower lung fields and trace bilateral lower extremity edema.Preoperative chest x-ray demonstrated clear lung fields, no pneumothorax or pleural effusions, and a normal cardiac and mediastinal silhouette.The patient was to undergo a four-vessel cabg via median sternotomy with left internal mammary artery harvest and endoscopic saphenous vein harvest; grafting was planned to the left anterior descending artery, the first marginal artery, the first diagonal artery, and the right coronary artery.The patient had a history of a prior difficult intubation due to an anterior larynx, so video laryngoscopy was planned for airway management.Peripheral intravenous access was established and a radial artery catheter was inserted in the preoperative holding area using intradermal lidocaine infiltration.The patient was brought to the operating room and monitors were applied (pulse oximetry, invasive blood pressure via radial artery catheter, 5-lead electrocardiogram, cerebral oximetry, and processed electroencephalogram).The patient was preoxygenated with 100% o2, and after reaching an end-tidal o2 of 80%, anesthesia was induced with etomidate- 14 mg, lidocaine- 70 mg, and fentanyl- 300 mcg; rocuronium- 70 mg, was used for muscle relaxation to facilitate endotracheal intubation.Mask ventilation was performed with the assistance of an oral airway and the trachea was easily intubated with an 8.0-mm endotracheal tube (ett) using a video laryngoscope with cormack-lehane grade 1 view; correct placement was determined by capnometry, palpation of the ett cuff, and auscultating bilateral breath sounds.Anesthesia was maintained with isolflurane 0.8% in oxygen.Central venous access was obtained with a 9-french percutaneous sheath introducer that was easily inserted in the right internal jugular vein in one attempt.A pulmonary artery catheter was advanced through the introducer until appropriate position was confirmed through pressure waveform.Transesophageal echocardiogram examination was performed to evaluate cardiac structures.The surgery commenced without incident.Ventilation was held at the time of sternotomy.Upon resuming ventilation, full tidal volumes were not being delivered and a ¿circuit leak¿ alarm activated, though inspection of the ventilator circuit showed no faulty connections.Flexible fiberoptic bronchoscopy was performed through the ett to evaluate its position, which was noted to be satisfactory.The pilot balloon on the ett cuff appeared underinflated, so additional air was added.Tidal volumes improved temporarily, but gradually decreased, and the ett cuff required frequent reinflation.Because the cuff leak became prominent around the time of sternotomy, the surgical team was asked to inspect the trachea for any iatrogenic injury.Visual inspection was unrevealing and irrigation with saline while holding continuous airway pressure at 30 cm h2o showed no air leak from the trachea.At this point, it was felt that the air leak was most likely owing to ett cuff damage, possibly from the ett cuff making contact with the patient¿s teeth or the video laryngoscope blade at the time of intubation.A discussion between the surgical and anesthetic teams determined that the best course of action would be to exchange the ett at the end of the surgery before transfer to the cardiovascular intensive care unit (cvicu) to continue postoperative mechanical ventilation.The patient was weaned from cardiopulmonary bypass (cpb) on phenylephrine- 0.5 to 0.6 mcg/kg/min and epinephrine- 0.02 to 0.03 mcg/kg/min (infusions for hemodynamic support).A mediastinal and left pleural chest tube were placed, and the chest was closed.Ventilation was adequate in spite of continued circuit leak from the suspected ett cuff damage and improved whenever air was added to the cuff.Upon completing the surgery, the anesthesia team prepared to exchange the ett.Given the history of a prior difficult intubation, the plan for exchanging the tube was to use a 19-french 83 cm cook airway exchange catheter to maintain a conduit within the trachea while also performing video laryngoscopy to visualize the glottic structures and displace any oropharyngeal soft tissue to facilitate passage of a new ett over the aec.Additional rocuronium- 35 mg was administered to the patient for muscle relaxation.Video laryngoscopy again showed a cormack-lehane grade 1 view and the aec was advanced through the ett.The depth was not noted, but was likely excessive; the aec had to be retracted in order to control the distal tip while loading the new ett.The second ett was easily advanced over the aec.Position was confirmed with capnometry and auscultation, and the ett was secured at 23 cm at the lip.Inspection of the initial ett revealed a hole in the cuff.The patient was transported to the cvicu on phenylephrine- 0.6 mcg/kg/min and epinephrine- 0.03 mcg/kg/min using a self-inflating resuscitator bag for ventilation with dexmedetomidine- 0.7 mcg/kg/hr for sedation.The patient had an oxygen saturation of 97% on 100% fio2, systemic blood pressure of 113/56 mmhg, pulmonary artery pressure of 31/10 mmhg, and a heart rate of 86 beats per minute with atrial-ventricular sequential pacing via epicardial leads before leaving the operating room.On arrival to the cvicu, the patient was connected to a ventilator and mechanical ventilation was resumed.The patient¿s oxygen saturation was 88% despite being ventilated with 100% fio2.Pulmonary artery pressure increased to 50/30 mmhg and the patient was hypotensive with a systemic blood pressure of 80/40 mmhg, despite increasing doses of epinephrine and phenylephrine.A portable chest x-ray was performed, which showed a large right-sided pneumothorax with right-to-left shift of the mediastinal structures that was concerning for tension pneumothorax.Emergent right-sided tube thoracostomy was performed immediately at the bedside with a large rush of air and dramatic improvement in oxygenation.Hemodynamics systemic blood pressure was 124/70 mmhg, pulmonary artery pressure was 38/18 mmhg, and oxygen saturation was 99%.The heart rate remained unchanged as the patient was atrial-ventricular paced.A repeat chest x-ray demonstrated a decrease in the size of the pneumothorax with the chest tube in adequate position and resolution of the right-to-left mediastinal shift.The patient was extubated 6 hours postoperatively.The post-operative course was largely uncomplicated: the mediastinal and left pleural chest tubes were removed on postoperative day (pod) 2, the right pleural chest tube was removed pod 3, and the patient was stable for downgrade from the cvicu to inpatient wards on pod 4.The patient was discharged to rehabilitation on pod 7.A repeat chest x-ray on pod 22 revealed no pneumothorax.Upon follow-up with his outpatient cardiologist, the patient had no cardiac or respiratory complaints.Literature citation: berguson, m., jan, r., morris, r.J.And goldhammer, j.E.(2019).An uncommon cause of cardiovascular collapse after cardiac surgery: tension pneumothorax following the use of an airway exchange catheter.Journal of cardiothoracic and vascular anesthesia, 33, 3409-3413.Doi: https://doi.Org/10.1053/j.Jvca.2019.07.150.
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Manufacturer Narrative
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Investigation ¿ evaluation: an over insertion of a cook airway exchange catheter (rpn: c-cae-19.0-83, lot number unknown) was reported in the article ¿an uncommon cause of cardiovascular collapse after cardiac surgery: tension pneumothorax following the use of an airway exchange catheter¿.The patient was a 75-year-old male with severe multi-vessel coronary artery disease and worsening anginal symptoms whom presented for elective coronary artery bypass (cabg) graft surgery.Peripheral intravenous access and a radial artery catheter were inserted in the preoperative holding area using intradermal lidocaine infiltration.Upon arrival to the operating room, monitors for pulse oximetry, invasive blood pressure monitoring, 5-lead electrocardiogram, cerebral oximetry, and a processed electroencephalogram were applied to the patient.The patient was pre-oxygenated with 100% oxygen.When the end tidal oxygen was 80%, anesthesia was induced using the following medications: etomidate (14 mg), lidocaine (70 mg), fentanyl (300 micrograms).Rocuronium (70mg) was used for muscle relaxation to facilitate endotracheal intubation.An 8.0 endotracheal tube (ett) was placed using a video laryngoscope.The patient had a cormack-lehane grade one view.To confirm correct placement of the ett placement, capnometry, palpitation of the ett cuff and auscultation of bilateral breath sounds was completed.The anesthesia was maintained with 0.8% isoflurane in oxygen.A 9 french sheath was inserted percutaneously into the internal jugular vein to assist with the insertion of a pulmonary artery catheter.The placement of the catheter was confirmed by pressure waveform.Evaluation of the cardiac structures was confirmed by transesophageal echocardiogram.The surgery commenced without incident.Ventilation was held at the time of sternotomy.When ventilation resumed full tidal volumes were not being delivered and a ¿circuit leak¿ alarm activated.Connections were inspected and no faulty connections were discovered.Flexible fiberoptic bronchoscopy was performed through the ett to evaluate its position, which was noted to be satisfactory.The pilot balloon on the ett cuff appeared underinflated so additional air was added, and the tidal volumes improved temporarily, however, the tidal volumes gradually decreased and the ett cuff required frequent reinflation.Because the cuff leak became prominent around the time of sternotomy, the surgical team was asked to inspect the trachea for any iatrogenic injury.No air leak from the trachea was discovered.At this point, it was felt that the air leak was most likely owing to ett cuff damage.The surgical and anesthetic teams planned to exchange the ett at end of surgery before transferring to the cardiovascular intensive care unit (cvicu) to continue postoperative mechanical ventilation.The patient was weaned from cardiopulmonary bypass.Mediastinal and left plural chest tubes were placed and the chest was closed.Ventilation was adequate in spite of continued circuit leak from the suspected ett cuff damage and improved whenever air was added to the cuff.Upon surgery completion, the anesthesia team prepared for ett exchange.A cook airway exchange catheter (aec) was used along with video laryngoscopy due to the patient¿s history of difficult intubation.The patient again had a grade one cormack-lehane view and the aec was advanced through the ett.The depth of the aec was not noted, but the authors state it was likely excessive.The aec had to be retracted to control the distal tip while loading on the new ett.The new ett advanced over the aec easily.The ett position was secured at 23 cm at the lip.Its placement was confirmed with capnometry and auscultation.Inspection of the initial ett tube that was removed confirmed a hole in the cuff.The patient was transported to the cvicu on phenylephrine, 0.6 mcg/kg/min, and epinephrine, 0.03 mcg/kg/min, using a self-inflating resuscitator bag for ventilation with dexmedetomidine, 0.7 mcg/kg/hr, for sedation.The patient had an oxygen saturation of 97% on 100% fio2, systemic blood pressure of 113/56 mmhg, pulmonary artery pressure of 31/10 mmhg, and a heart rate of 86 beats per minute with atrial-ventricular sequential pacing via epicardial leads before leaving the operating room.On arrival to the cvicu, the patient was connected to the ventilator and mechanical ventilation was resumed.The patient¿s oxygen saturation was 88% despite being ventilated with 100% fio2.Pulmonary artery pressure increased to 50/30mmhg and the patient was hypotensive with systemic blood pressure of 80/40 mmhg despite increasing doses of epinephrine and phenylephrine.A portable chest x-ray was performed, which showed a large right-sided pneumothorax with right-to-left shift of the mediastinal structures that was concerning for tension pneumothorax.An emergent right-sided thoracostomy tube was placed.Dramatic improvements in the patient¿s oxygenation and hemodynamics were observed: systemic blood pressure 124/70 mmhg, pulmonary artery pressure 38/18 mmhg, oxygen saturation 99%, heart rate continued to be 86 bpm (the patient was atrial-ventricular paced).A repeat chest x-ray was completed.The chest tube position was confirmed, the right-to-left mediastinal shift was resolved, and the pneumothorax had decreased in size.Six hours postoperative, the patient was extubated.On postoperative day two, the mediastinal and left pleural chest tubes were removed.On postoperative day three the right pleural chest tube was removed.The patient was downgraded in acuity and transferred to an inpatient ward on postoperative day four.On postoperative day 7 the patient was discharged.A repeat chest x-ray on pod 22 demonstrated no pneumothorax and upon follow-up with his outpatient cardiologist, the patient had no cardiac or respiratory complaints.Cited work: berguson, m., jan, r., morris, r.J.And goldhammer, j.E.(2019).An uncommon cause of cardiovascular collapse after cardiac surgery: tension pneumothorax following the use of an airway exchange catheter.Journal of cardiothoracic and vascular anesthesia, 33, 3409-3413.Doi: https://doi.Org/10.1053/j.Jvca.2019.07.150 reviews of documentation including the complaint history, quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: order number used for c-cae-11.0-83 for use in replacement of endotracheal tubes whoe inner diameter (id) is 4mm or larger (inner diameter: 2.3mm) c-cae-11.0-100-dlt-ef for use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (id) is 4mm or larger c-cae-11.0-100-dlt-ef-st (inner diameter: 2.3mm) warnings: attention should be paid to insertion depth of catheter into patient`s airway and correct tracheal position of replacement endotracheal tube.Markers on the cook airway exchange catheter refer to distance from tip of catheter.Catheter and endotracheal tube should not be advanced beyond the carina.To avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3cm.Potential adverse events: barotrauma , perforation of the bronchi or lung parenchyma.Endotracheal tube exchange 1.Before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be replaced, confirm correct endotracheal tube position.2.Using the outer margin of the patient`s mouth or nasal orifice as a landmark, note the marking on the endotracheal tube.A piece of tape or other marker may be placed on the cae catheter at the corresponding distance from the tip to aid in correct placement within the endotracheal tube.Caution: to avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3 cm.Note: if a high pressure oxygen source is used for insufflation (e.G.Jet ventilator), begin at lower pressure and work up gradually.Rising chest wall, pulse oximetry and oral air flow should be carefully monitored.Based on the available information, no product returned, and the results of the investigation, cook has concluded the most likely cause of this event to be over insertion of the cook airway exchange catheter.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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